A 2-part study to assess local tolerability, safety and pharmacokinetics of ceftaroline in healthy subjects

Study identifier:D3720C00015

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Single-center, 2-part, Randomized, 2-way Crossover Study to Assess the Local Tolerability and Safety (Multiple-dose) and to Assess the Pharmacokinetics, Safety, and Tolerability (Single-dose) of Ceftaroline in Healthy Subjects when Ceftaroline Fosamil is Diluted in Various Infusion Volume

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

600 mg ceftaroline fosamil in 50 ml infusion volume, Placebo in 50 ml infusion volume, 600 ceftaroline fosamil in 250 ml infusion volume, Placebo in 250 ml infusion volume, 600 mg ceftaroline in 100 ml infusion volume, Placebo in 100 ml infusion volume

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 01 Apr 2012

Primary Completion Date: 01 Sept 2012

Study Completion Date: 01 Sept 2012

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Jul 2014 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research site

London, United Kingdom

Arms	Assigned Interventions
Experimental: A 600 mg ceftaroline fosamil in 50 ml infusion volume	Drug: 600 mg ceftaroline fosamil in 50 ml infusion volume IV infusion
Placebo Comparator: B Placebo in 50 ml infusion volume	Drug: Placebo in 50 ml infusion volume IV infusion
Experimental: C 600 ceftaroline fosamil in 250 ml infusion volume	Drug: 600 ceftaroline fosamil in 250 ml infusion volume IV infusion
Placebo Comparator: D Placebo in 250 ml infusion volume	Drug: Placebo in 250 ml infusion volume IV infusion
Experimental: E 600 mg ceftaroline in 100 ml infusion volume	Drug: 600 mg ceftaroline in 100 ml infusion volume IV infusion
Placebo Comparator: F Placebo in 100 ml infusion volume	Drug: Placebo in 100 ml infusion volume IV infusion

"There is no result for the study"

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1378&filename=CSR-D3720C00015.pdf
Download
CSR-D3720C00015.pdf
Download
Clinical Study Protocol Redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

Hammersmith Reserach

0800 783 8792

recruit@hmrlondon.com

Contact Backup

Hammersmith Reserach

0800 783 8792

recruit@hmrlondon.com

Investigators

Principal Investigator

David Melnick

AstraZeneca PharmaceuticalsC2C-7161800 Concord PikePO. Box 15437Wilmington De 19850-5437